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Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial

NCT ID: NCT05079880

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2021-10-30

Brief Summary

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A faster emergence from general anesthesia has a double medico-economic impact by reducing the risks of complications and optimizing the performance of surgical units. No drug has been retained for its ability to actively accelerate anesthetic emergence by antagonizing hypnotics. Thus, the aim of this study was to examine the effect of caffeine on the time to emerge from sevoflurane anesthesia for laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GC group

received 300 mg of caffeine citrate infusion

Group Type EXPERIMENTAL

300 mg of caffeine citrate infusion

Intervention Type DRUG

At the end of the surgery, the study drug was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period

GS group

Equivalent saline infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

At the end of the surgery, the placebo was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period

Interventions

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300 mg of caffeine citrate infusion

At the end of the surgery, the study drug was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period

Intervention Type DRUG

Placebo

At the end of the surgery, the placebo was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American society of Anesthesiologists (ASA) I and II patients, aged older than 18 years old and scheduled for laparoscopic cholecystectomy

Exclusion Criteria

* Patient with an allergy to caffeine citrate and analgesics used during postoperative period, those with severe renal or hepatic failure, those who refused to participate in addition to patient with heart rhythm disorder, seizure disorder, hypertension, alcoholic or psychiatric illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tunis University

OTHER

Sponsor Role lead

Responsible Party

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Daghmouri Mohamed Aziz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Habib Thameur Hospital

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Mohamed Aziz DAGHMOURI, M.D

Role: CONTACT

[email protected]
0021629442474

Facility Contacts

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Mohamed Aziz Daghmouri

Role: primary

[email protected]

Other Identifiers

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HTHEC-2017-09

Identifier Type: -

Identifier Source: org_study_id